UMIN-CTR Clinical Trial

Public title

Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety

Acronym

Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety

Scientific Title

Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety

Scientific Title:Acronym

Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety

Region

Japan

Condition

N/A(healthy adaults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effects of a test food for improvement of skin moisturizing function and its safety for subjects by 8-week ingestion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Transepidermal water loss (Screening, Week 0, Week 4, Week 8)
[2]Skin moisture content (Screening, Week 0, Week 4, Week 8)

Key secondary outcomes

*Secondary outcomes
[1]Visual evaluation (Screening, Week 0, Week 4, Week 8)

*Other index
[1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8)

*Safety evaluation
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8)
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8)
[3]Hematologic test (Screening, Week 0, Week 8)
[4]Blood biochemical test (Screening, Week 8)
[5]Blood test (Screening, Week 0, Week 8)
[6]Urine analysis (Screening, Week 0, Week 8)
[7]Doctor's questions (Screening, Week 0, Week 4, Week 8)
[8]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food (8 weeks)

Interventions/Control_2

Oral ingestion of the placebo food A (8 weeks)

Interventions/Control_3

Oral ingestion of the placebo food B (8 weeks)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese females aged 30-59 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals who are anxious about skin dryness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who use a drug to treat a disease in the past 1 month.
[3]Individuals with skin disease, such as atopic dermatitis.
[4]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[5]Individuals who contract or have a history of serious endocrine disease.
[6]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg.
[7]Individuals whose BMI is over 30.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[9]Individuals with serious anemia.
[10]Individuals who are sensitive to a test producer other foods, and medical products.
[11]Individuals who are or are possibly, or are lactating.
[12]Individuals who are alcoholism or mental disorders.
[13]Individuals who have a habit of smoking.
[14]Individuals whose bowel habit is irregular.
[15]Individuals whose life style will change during the test period.
[16]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[17]Individuals who will get sunburned during the test period (including winter sports like skiing and snowboarding).
[18]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[19] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[20] Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle.
[21]Individuals who had been conducted an operation on the test spot in the past 6months.
[22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[23]Individuals who are or whose family is engaged in healthy or functional foods.
[24]Individuals judged inappropriate for the study by the principal.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Takahiro Ono

Organization

Medical Corporation Wakei-kai Medics Hongo Clinic

Division name

Director

Zip code

Address

2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN

TEL

03-6801-9761

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

LG Household & Health Care Ltd

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Korea

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

07

Day

Last modified on

2017

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029915